Principal Business Analyst, Regulatory Affairs IT (R&D IT)
About The Position
The Senior Business Analyst for Regulatory Affairs IT will be responsible for developing relationships with Regulatory stakeholders, surfacing unmet IT needs and project requests, and managing portfolios of software products and IT projects. S/he will serve as a strategic IT liaison to the Regulatory organization and will translate process based business needs into technical solutions. S/he will be expected to partner with the Sr. IT Business Partner and Regulatory Affairs organization to help develop a strategic roadmap, elicit needs-based requirements, and communicate with our Regulatory staff to assure their understanding of the fit of solutions to business processes. S/he will focus on building strong partnerships and delivering strategic, operational and meaningful IT solutions. The key activities for this position include: Draw from past Regulatory experiences to develop solutions to complex problems that require a high degree of ingenuity, creativity and innovation within the boundaries of industry compliance regulations. Facilitate business requirements gathering process through best practices and work with the technical teams to develop technical requirements. Assist in solutions identification, selection, testing and implementation, whether commercial applications or new in-house development. Serves as a "super user", trainer, and technical/functional software support expert during implementations and for prototypes & pilots; serve as an in-house expert and promoter for our application portfolio. Work with the ITFL to establish a business partnership to ensure close collaboration between Regulatory and IT. Work with the ITFL to translate business needs into an actionable IT Roadmap to support prioritization and solution proposals in line with shared processes, data harmonization, and architectural direction. Collaborate with business leads to develop business cases for projects.
Requirements
- Minimum of 3-5 years' experience as a business analyst, with command of business analysis techniques & tools, as well as SDLC & iterative systems development methodologies, in the biotech or pharmaceutical industry.
- Minimum of 3-5 years' experience as
Responsibilities
- Draw from past Regulatory experiences to develop solutions to complex problems that require a high degree of ingenuity, creativity and innovation within the boundaries of industry compliance regulations.
- Facilitate business requirements gathering process through best practices and work with the technical teams to develop technical requirements.
- Assist in solutions identification, selection, testing and implementation, whether commercial applications or new in-house development.
- Serves as a "super user", trainer, and technical/functional software support expert during implementations and for prototypes & pilots; serve as an in-house expert and promoter for our application portfolio.
- Work with the ITFL to establish a business partnership to ensure close collaboration between Regulatory and IT.
- Work with the ITFL to translate business needs into an actionable IT Roadmap to support prioritization and solution proposals in line with shared processes, data harmonization, and architectural direction.
- Collaborate with business leads to develop business cases for projects.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
No Education Listed
